Cleared Special

K043427 - DURAGEN II DURAL REGENERATION MATRIX

K043427 is an FDA 510(k) clearance for DURAGEN II DURAL REGENERATION MATRIX, manufactured by Integra Lifesciences Corp.. The device is a Class 2 Neurology device with product code GXQ cleared through the Special 510(k) pathway after a 30-day FDA review.

K043427 · Integra Lifesciences Corp. · Neurology device
Download Printable Device Report (PDF)
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Jan 2005
Decision
30d
Days
Class 2
Risk

K043427 is an FDA 510(k) clearance for the DURAGEN II DURAL REGENERATION MATRIX. Classified as Dura Substitute (product code GXQ), Class II - Special Controls.

Submitted by Integra Lifesciences Corp. (Plainsboro, US). The FDA issued a Cleared decision on January 12, 2005 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5910 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Integra Lifesciences Corp. devices

FDA 510(k) Submission Details - K043427

510(k) Number K043427 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2004
Decision Date January 12, 2005
Days to Decision 30 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
118d faster than avg
Panel avg: 148d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

GXQ Device Classification - Class 2, Special Controls

Product Code GXQ Dura Substitute
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5910
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - GXQ Dura Substitute

All 41
Devices cleared under the same product code (GXQ) and FDA review panel - the closest regulatory comparables to K043427.
MODIFICATION TO DUREPAIR DURA REGENERATION MATRIX
K063117 · Medtronic Neurosurgery · Nov 2006
DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE - ONLAY AND SUTURABLE
K061487 · Collagen Matrix, Inc. · Jun 2006
DUREPAIR DURA REGENERATION MATRIX
K052211 · Medtronic Neurosurgery · Sep 2005
DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE
K040888 · Collagen Matrix, Inc. · Dec 2004
DUREPAIR DURA REGENERATION MATRIX
K041000 · Medtronic Neurosurgery · Jul 2004
CODMAN DURAFORM DURAL GRAFT IMPLANT
K041518 · Codman & Shurtleff, Inc. · Jun 2004